Wednesday, November 26, 2003

Effort underway to improve quality of life and survivability for cancer patients

Medical breakthrough may be close at hand

Three years ago, Dr. Melanie Bone, 43, a gynecologist from West Palm Beach, Fla., was fighting for her life. She had been diagnosed with stage three breast cancer, which required aggressive treatment. She underwent a bilateral mastectomy, then endured six months of chemotherapy and 33 radiation treatments before finally being declared cancer free.

“Chemotherapy is what ultimately cured me of cancer, but I wouldn’t wish it on my worst enemy. I was sick all the time, said Dr. Bone.

While undergoing treatment, she became anemic, lost all her hair and her ability to taste and smell. “The sores and ulcers that formed in my mouth made drinking and eating very uncomfortable. At one point, my white blood count got so low, I had to actually move out of my house. I have four kids and my doctor was concerned they’d bring home a bug I couldn’t fight off,” said Dr. Bone.

Chemotherapy drugs are very effective, but since they are indiscriminate — meaning they target both cancer and healthy cells — they can be toxic. Pro-Pharmaceuticals, a drug development company in Newton, Mass., is conducting human trials right now on a new drug that targets cancer cells and leaves healthy cells alone. It’s called DAVANAT-1.

“It’s a sugar-based compound we believe can increase the human body’s tolerance to highly toxic chemotherapy drugs,” said Dr. David Platt, CEO of Pro-Pharmaceuticals.

DAVANAT-1 is a combination of the highly effective chemotherapy drug 5-FU and DAVANAT, a carbohydrate compound named after Dr. Platt and Dr. Anatole Klyosov, the two scientists who developed it. “It is a sugar that looks for specific receptors found only on the outside walls of cancer cells. This particular carbohydrate is attracted to the lectin Galactin 3,” said Dr. Platt.

DAVANAT encapsulates the anti-cancer drug prior to binding to the over-expressed lectin receptors and guides them to the nucleus of the cancer cells. When inside the cancer cell, the anti-cancer drug cleaves from DAVANAT and destroys the cancer cell. By encompassing the anti-cancer drug, DAVANAT, prevents the drug from being absorbed by normal healthy cells thereby reducing the anti-cancer drug’s overall toxic effects on the body.

In preclinical trials on mice, 400 percent greater levels of the cancer drug, 5-FU, effectively targeted tumors in mice injected with Davanat-1. Since the healthy cells were left alone, side effects -- such as nausea, hair loss, and fatigue were minimal.

Human trials of the drug started this past February at four sites: Dartmouth-Hitchcock in Lebanon, N.H., the University of Michigan, Ann Arbor, Ochsner Cancer Institute in New Orleans and Florida Oncology Associates in Jacksonville, Fla. All of the patients invited to participate are considered refractory patients — meaning this is their last hope. They are in advanced stages of cancer and conventional treatments — radiation, surgery and chemotherapy alone — have failed them.

“If the preclinical trial results are any indication, we may have a lot of miracles in the works,” said Dr. Platt. “Of the mice injected only with 5-FU, 65 percent died. We had a 100-percent survival rate for mice that received Davant-1.”

“The treatment sounds very promising,” said Dr. Bone. “I’m looking forward to seeing the results of the human trials.”

Once the results of the Phase l human trials are reported, sometime next year, to the Food and Drug Administration, the FDA will decide whether DAVANAT-1 should be added to the arsenal of cancer fighting drugs.

For more details about the study, log onto www.pro-pharmaceuticals.com or www.clinicaltrials.gov (keyword: DAVANAT).